Airway implants and methods and devices for insertion and retrieval

ABSTRACT

Embodiments of the present invention relate to methods and devices for the treatment of airway obstruction, such as obstructive sleep apnea, and devices and methods that facilitate insertion and retrieval of the same. In one embodiment, disclosed is a tissue tensioner that includes an elongate flexible tether having a first end and a second end, a bone anchor configured to be connected to a patient&#39;s mandible, a tissue ingrowth implant configured to be implanted in a patient&#39;s tongue and connected to the second end of the tether, and an adjustment mechanism configured to be held by the bone anchor adjacent the patient&#39;s mandible and configured to receive the first end of the tether and configured to adjust tension in the flexible tether between the patient&#39;s mandible and tongue. Various anchors, tethers, securement mechanisms, and adjustment mechanisms that can be used with glossal and palatal remodeling systems are also disclosed.

The present application which claims priority under 35 U.S.C. §119(e)claims priority to U.S. patent application Ser. No. 13/350,867, filed onJan. 16, 2012, which claims priority under 35 U.S.C. §119(e) to U.S.patent application Ser. No. 11/835,931, filed on Aug. 8, 2007, whichclaims priority under 35 U.S.C. §119(e) to U.S. Provisional ApplicationNo. 60/836,579 filed on Aug. 8, 2006. The present application alsoclaims priority under 35 U.S.C. §120 as a continuation-in-part of U.S.patent application Ser. No. 11/349,044, filed Feb. 7, 2006, which claimspriority to U.S. Provisional Application Nos. 60/650,867 filed Feb. 8,2005 and 60/726,028 filed Oct. 12, 2005. All of the priorityapplications are hereby incorporated by reference in their entirety.

BACKGROUND

1. Field of the Invention

Certain embodiments of the present invention are related to methods anddevices for the treatment of airway obstruction, such as, for example,obstructive sleep apnea, and devices and methods that facilitateinsertion and retrieval of the same.

2. Field of the Invention

This invention relates generally to a system and method for treatingupper airway obstruction, sleep disordered breathing, upper airwayresistance syndrome and snoring by manipulating the structures of theoropharynx, including the tongue.

3. Description of the Related Art

Respiratory disorders during sleep are recognized as a common disorderwith significant clinical consequences. During the various stages ofsleep, the human body exhibits different patterns of brain and muscleactivity. In particular, the REM sleep stage is associated with reducedor irregular ventilatory responses to chemical and mechanical stimuliand a significant degree of muscle inhibition. This muscle inhibitionmay lead to relaxation of certain muscle groups, including but notlimited to muscles that maintain the patency of the upper airways, andcreate a risk of airway obstruction during sleep. Because musclerelaxation narrows the lumen of the airway, greater inspiratory effortmay be required to overcome airway resistance. This increasedinspiratory effort paradoxically increases the degree of airwayresistance and obstruction through a Bernoulli effect on the flaccidpharyngeal walls during REM sleep.

Obstructive Sleep Apnea (OSA) is a sleep disorder that affects up to 2to 4% of the population in the United States. OSA is characterized by anintermittent cessation of airflow in the presence of continuedinspiratory effort. When these obstructive episodes occur, an affectedperson will transiently arouse, regain muscle tone and reopen theairway. Because these arousal episodes typically occur 10 to 60 timesper night, sleep fragmentation occurs which produces excessive daytimesleepiness. Some patients with OSA experience over 100 transient arousalepisodes per hour.

In addition to sleep disruption, OSA may also lead to cardiovascular andpulmonary disease. Apnea episodes of 60 seconds or more have been shownto decrease the partial pressure of oxygen in the lung alveoli by asmuch as 35 to 50 mm Hg. Some studies suggest that increasedcatecholamine release in the body due to the low oxygen saturationcauses increases in systemic arterial blood pressure, which in turncauses left ventricular hypertrophy and eventually left heart failure.OSA is also associated with pulmonary hypertension, which can result inright heart failure.

Radiographic studies have shown that the site of obstruction in OSA isisolated generally to the supralaryngeal airway, but the particular siteof obstruction varies with each person and multiple sites may beinvolved. A small percentage of patients with OSA have obstructions inthe nasopharynx caused by deviated septums or enlarged turbinates. Theseobstructions may be treated with septoplasty or turbinate reductionprocedures, respectively. More commonly, the oropharynx and thehypopharynx are implicated as sites of obstruction in OSA. Some studieshave reported that the occlusion begins with the tongue falling back inan anterior-posterior direction (A-P) to contact with the soft palateand posterior pharyngeal wall, followed by further occlusion of thelower pharyngeal airway in the hypopharynx. This etiology is consistentwith the physical findings associated with OSA, including a large baseof tongue, a large soft palate, shallow palatal arch and a narrowmandibular arch. Other studies, however, have suggested that increasedcompliance of the lateral walls of the pharynx contributes to airwaycollapse. In the hypopharynx, radiographic studies have reported thathypopharyngeal collapse is frequently caused by lateral narrowing of thepharyngeal airway, rather than narrowing in the A-P direction.

OSA is generally diagnosed by performing overnight polysomnography in asleep laboratory. Polysomnography typically includeselectroencephalography to measure the stages of sleep, anelectro-oculogram to measure rapid eye movements, monitoring ofrespiratory effort through intercostal electromyography or piezoelectricbelts, electrocardiograms to monitor for arrhythmias, measurement ofnasal and/or oral airflow and pulse oximetry to measure oxygensaturation of the blood.

Following the diagnosis of OSA, some patients are prescribed weight lossprograms as part of their treatment plan, because of the associationbetween obesity and OSA. Weight loss may reduce the frequency of apneain some patients, but weight loss and other behavioral changes aredifficult to achieve and maintain. Therefore, other modalities have alsobeen used in the treatment of OSA, including pharmaceuticals,non-invasive devices and surgery.

Among the pharmaceutical treatments, respiratory stimulants and drugsthat reduce REM sleep have been tried in OSA. Progesterone, theophyllineand acetozolamide have been used as respiratory stimulants, but eachdrug is associated with significant side effects and their efficacy inOSA is not well studied. Protriptyline, a tricyclic antidepressant thatreduces the amount of REM sleep, has been shown to decrease thefrequency of apnea episodes in severe OSA, but is associated withanti-cholinergic side effects such as impotence, dry mouth, urinaryretention and constipation.

Other modalities are directed at maintaining airway patency duringsleep. Oral appliances aimed at changing the position of the softpalate, jaw or tongue are available, but patient discomfort and lowcompliance have limited their use. Continuous Positive Airway Pressure(CPAP) devices are often used as first-line treatments for OSA. Thesedevices use a sealed mask which produce airflow at pressures of 5 to 15cm of water and act to maintain positive air pressure within thepharyngeal airway and thereby maintain airway patency. Although CPAP iseffective in treating OSA, patient compliance with these devices is lowfor several reasons. Sleeping with a sealed nasal mask is uncomfortablefor patients. Smaller sealed nasal masks may be more comfortable topatients but are ineffective in patients who sleep with their mouthsopen, as the air pressure will enter the nasopharynx and then exit theoropharynx. CPAP also causes dry nasal passages and congestion.

Surgical treatments for OSA avoid issues with patient compliance and areuseful for patients who fail conservative treatment. One surgery usedfor OSA is uvulopalatopharyngoplasty (UPPP). UPPP attempts to improveairway patency in the oropharynx by eliminating the structures thatcontact the tongue during sleep. This surgery involves removal of theuvula and a portion of the soft palate, along with the tonsils andportions of the tonsillar pillars. Although snoring is reduced in amajority of patients who undergo UPPP, the percentage of patients whoexperience reduced frequency of apnea episodes or improved oxygensaturation is substantially lower. Postoperatively, many patients thathave undergone UPPP continue to exhibit oropharyngeal obstruction orconcomitant hypopharyngeal obstruction. Nonresponders often havephysical findings of a large base of tongue, an omega-shaped epiglottisand redundant aryepiglottic folds. UPPP is not a treatment directed atthese structures. UPPP also exposes patients to the risks of generalanesthesia and postoperative swelling of the airway that will require atracheostomy. Excessive tissue removal may also cause velo-pharyngealinsufficiency where food and liquids enter into the nasopharynx duringswallowing.

Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar procedureto UPPP that uses a CO2 laser to remove the uvula and portions of thesoft palate, but the tonsils and the lateral pharyngeal walls are notremoved.

For patients who fail UPPP or LAUP, other surgical treatments areavailable but these surgeries entail significantly higher risks ofmorbidity and mortality. In genioglossal advancement with hyoid myotomy(GAHM), an antero-inferior portion of the mandible, which includes theattachment point of the tongue musculature, is repositioned forward andin theory will pull the tongue forward and increase airway diameter. Themuscles attached to the inferior hyoid bone are severed to allow thehyoid bone to move superiorly and anteriorly. Repositioning of the hyoidbone expands the retrolingual airspace by advancing the epiglottis andtongue base anteriorly. The hyoid bone is held in its new position byattaching to the mandible using fascia. Variants of this procedureattach the hyoid bone inferiorly to the thyroid cartilage.

A laser midline glossectomy (LMG) has also been tried in some patientswho have failed UPPP and who exhibit hypopharyngeal collapse onradiographic studies. In this surgery, a laser is used to resect themidline portion of the base of the tongue. This involves significantmorbidity and has shown only limited effectiveness.

In some patients with craniofacial abnormalities that include a recedingmandible, mandibular or maxillomandibular advancement surgeries may beindicated for treatment of OSA. These patients are predisposed to OSAbecause the posterior mandible position produces posterior tonguedisplacement that causes airway obstruction. In a mandibular advancementprocedure, the mandible is cut bilaterally posterior to the last molarand advanced forward approximately 10 to 14 mm. Bone grafts are used tobridge the bone gap and the newly positioned mandible is wire fixated tothe maxilla until healing occurs. Mandibular advancement may be combinedwith a Le Fort I maxillary osteotomy procedure to correct associateddental or facial abnormalities. These procedures have a high morbidityand are indicated only in refractory cases of OSA.

Experimental procedures described in the clinical literature for OSAinclude the volumetric radiofrequency tissue ablation and hyoidplasty,where the hyoid bone is cut into several segments and attached to abrace that widens the angle of the U-shaped hyoid bone. The latterprocedure has been used in dogs to increase the pharyngeal airway lumenat the level of the hyoid bone. The canine hyoid bone, however, isunlike a human hyoid bone because the canine hyoid bone comprises nineseparate and jointed bones, while the human hyoid bone comprises fivebones that are typically fused together.

Notwithstanding the foregoing, there remains a need for improved methodsand devices for treating obstructive sleep apnea.

SUMMARY OF THE INVENTION

Methods and devices for manipulating tissue are provided. Atissue-tensioner is used to tension a region of tissue. The tissuetensioner is used to engage certain tissue of the body and apply tensionto those tissues.

In further embodiments, methods and devices are disclosed formanipulating the tongue, or alternatively the soft palate. A tissueengaging structure can be positioned on the tongue, and the device ismanipulated to displace at least a portion of the posterior tongue in ananterior or lateral direction, or to alter the tissue tension orcompliance of the tongue.

In one embodiment, disclosed is a tissue tensioner for treating acondition of a patient's airway, said tissue tensioner including anelongate flexible tether having a first end and a second end; a boneanchor configured to be connected to a patient's mandible; and a tissueingrowth implant configured to be implanted in a patient's tongue. Thetissue ingrowth implant can be connected to the second end of thetether. The tissue tensioner can also include an adjustment mechanismconfigured to be held by the bone anchor adjacent the patient'smandible. The adjustment mechanism can be configured to receive thefirst end of the tether, as well as configured to adjust tension in theflexible tether between the patient's mandible and the patient's tongue.In some embodiments the elongate member can include either an activevariable length tether or a coating tending to cause tissue ingrowth.The adjustment mechanism can include a rotational assembly such as aspool.

In one embodiment, disclosed is a tissue tensioner for treating acondition of a patient's airway, the tensioner including an elongateflexible tension member; a first portion of the tension memberconfigured to be secured relative to a body tissue; and a second portionof the tension member including a tissue ingrowth material configured tobe secured to a portion of a tongue; and an adjustment mechanismconfigured to adjust tension in the tension member between the bodytissue and said portion of the tongue. In some embodiments the firstportion of the tension member can be connected to either a bone anchoror a tissue anchor. In some embodiments the tissue ingrowth material isa single strand of woven material which may be partially covered by acap element. The cap element can be radiopaque. The tension member canbe beaded in some embodiments.

In one embodiment, a method for treating airway obstruction isdisclosed. The method includes the steps of placing a tissue tensionerwithin a patient's tongue, the tensioner including a flexible elongatetension member having a first portion configured to be secured relativeto a body tissue and a second portion that is connected to a tissueingrowth material; an adjustment mechanism configured to adjust tensionin the tension member between the body tissue and the tissue ingrowthmaterial; securing the first portion relative to a body tissue andimplanting the tissue ingrowth material within a portion of the tongue;and adjusting the tension of the tension member by manipulating theadjustment mechanism. In some embodiments the first portion is eithersecured relative to a patient's mandible using a bone anchor, or securedto tongue tissue using a tissue anchor. In some embodiments, the tissueingrowth implant includes a single strand of woven material.

In another embodiment, disclosed is a tissue tensioner for treating acondition of a patient's airway, including an elongate flexible tensionmember comprising a first portion and a second portion; the firstportion of the tension member being securable relative to a body tissue;the second portion being connected to a tissue ingrowth material; andmeans for adjusting the tension between the tissue ingrowth material andthe body tissue. In some embodiments, the first portion of the tensionmember can be configured to be connected to either a bone anchor or atissue anchor.

In another embodiment, disclosed is a tissue tensioner for treating acondition of a patient's airway that includes a flexible elongatetension member having a first portion and a second portion. The firstportion can be securable relative to a body tissue, and the secondportion can be connected to an implant including a single woven strandand configured to be implanted in a patient's tongue. A cap element cancover a portion of the woven implant.

In one embodiment, disclosed is a method for treating airway obstructionincluding the steps of deploying a tissue tensioner into a patient'stongue, the tissue tensioner including a flexible elongate tensionmember having a first portion secured relative to a body tissue and asecond portion including a single strand woven implant that can beimplanted in a patient's tongue. In some embodiments, the method alsoincludes the step of removing the tissue tensioner from the patient bypulling on the single strand with sufficient force such that the wovenimplant unravels. The first portion may be secured either relative tothe patient's mandible or within the patient's tongue.

In one embodiment, disclosed is a tissue tensioner for treating acondition of a patient's airway including a flexible elongate elasticmember having a first portion and a second portion, wherein the firstportion is configured to be secured relative to a body tissue and thesecond portion is connected to a tissue ingrowth material; and a lockingbar releasably attached to the first portion and the second portion. Thelocking bar can be configured to prevent migration of the first portionrelative to the second portion.

In one embodiment, disclosed is a method for treating a condition of apatient's airway, the method including the step of positioning a tissuetensioner within a patient. The tissue tensioner can include a flexible,elongate elastic member having a first portion secured relative to abody tissue and a second portion comprising a tissue ingrowth materialimplanted in a portion of the tongue. A locking bar is preferablyreleasably attached to the first portion and the second portion toprevent migration of the first portion with respect to the secondportion. The locking bar can be manually pulled out to allow migrationof the first portion with respect to the second portion.

In yet another embodiment, disclosed is a method for removing a tissuetensioner including the steps of providing a tissue tensioner, thetissue tensioner comprising a batten implant connected to a flexibletether; threading the flexible tether through a dilator; advancing thedilator over the flexible tether through tissue to the batten implant;advancing a cannula over dilator and over the implant; and removing thebatten implant, the cannula, and the dilator. In some embodiments, atleast a portion of the tissue ingrowth material is covered by a capelement.

In one embodiment, disclosed is a method for treating a condition of apatient's airway, including the steps of passing a first tension memberthrough a patient's genioglossus muscle exiting the dorsum lateral to amidline of the patient's tongue creating a first exit hole; passing asecond tension member through the patient's genioglossus muscle exitingthe dorsum lateral to the midline of the patient's tongue creating asecond exit hole; passing a sling element under the tongue surfacethough the first exit hole and the second exit hole; attaching the firsttension member to a first portion of the sling; attaching the secondtension member to a second portion of the sling; and securing first andsecond tension members relative to body tissue. In some embodiments thefirst and second tension members are secured to bone anchors.

In another embodiment, disclosed is a method for treating airwayobstruction including the steps of placing a tissue tensioner within apatient's oral cavity, the tensioner including a flexible elongatetension member having a first portion configured to be secured relativeto a body tissue and a second portion that is connected to a tissueingrowth material; an adjustment mechanism configured to adjust tensionin the tension member between the body tissue and the tissue ingrowthmaterial; securing the first portion relative to a body tissue andimplanting the tissue ingrowth material within a portion of thepatient's soft palate; and adjusting the tension of the tension memberby manipulating the adjustment mechanism. In some embodiments the firstportion is secured relative to a patient's hard palate.

In still another embodiment, disclosed is a tissue tensioner fortreating a condition of an airway, the tissue tensioner including: anelongate flexible tension member, a first portion of the tension memberconnected to a first tissue ingrowth material and a second portion ofthe tension member connected to a second tissue ingrowth material; andan adjustment mechanism configured to adjust tension in the tensionmember between the first tissue ingrowth material and the second tissueingrowth material. In some embodiments the first tissue ingrowthmaterial is implanted in a first body tissue and the second tissueingrowth material is implanted in a second body tissue.

In yet another embodiment, disclosed is a method for treating airwayobstruction, the method including placing a tissue tensioner within thetongue, the tensioner including a flexible elongate tension memberhaving a first portion connected to a first tissue ingrowth material anda second portion connected to a second tissue ingrowth material;implanting the first tissue ingrowth material in a first portion of thetongue and implanting the second tissue ingrowth material in a secondportion of the tongue; and adjusting the tension or length of thetension member by manipulating an adjustment mechanism configured toadjust tension in the tension member between the first tissue ingrowthmaterial and the second tissue ingrowth material.

In another embodiment, disclosed is a tissue tensioner for treating acondition of a patient's airway, the tissue tensioner including anelongate flexible tension member, a first portion of the tension memberincluding a tissue anchor configured to be secured to a first portion ofa patient's tongue and a second portion of the tension member includinga tissue ingrowth material configured to be secured to a second portionof the patient's tongue. The tissue anchor may include a fishbone anchorthat has a plurality of barbs extending radially from the tensionmember.

In another embodiment, disclosed is a method for treating airwayobstruction including placing a tissue implant within a patient's tongueor palate, the tissue implant comprising a multiple-pronged stiffeningelement; and expanding the stiffening element within the tongue orpalate to stretch tissue laterally. The stiffening implant may have atleast one, two, three, four, five, or more prongs.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates tongue and soft palate implants including adjustmentelements to adjust the tension of a tether, according to one embodimentof the invention.

FIG. 2 is a schematic diagram showing one example of a securementassembly that may be used with a tongue or hyoid suspension system,according to one embodiment of the invention.

FIG. 3 shows tongue and soft palate implants comprising tethers with abeaded shape, according to one embodiment of the invention.

FIGS. 4A-C depict a tongue suspension system comprising a multi-piecesling, according to one embodiment of the invention.

FIG. 5 shows a tongue suspension system with an elongated membercomprising a double-ended anchor, according to one embodiment of theinvention.

FIGS. 6A-B illustrate an anchor with a plurality of barbs that may beself-expandable, according to one embodiment of the invention.

FIGS. 7A-B show an implant comprising a multi-pronged stiffeningelement, according to one embodiment of the invention.

FIGS. 8A-B illustrate a woven tissue implant that can be convenientlyremoved after implantation, according to one embodiment of theinvention.

FIGS. 9A-C show a tissue implant that comprises a locking rod, accordingto one embodiment of the invention.

FIGS. 10A-C illustrate a recapture/removal tool for a batten-styleimplant, according to one embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Causes of airway obstruction include but are not limited to obstructivesleep apnea, snoring and congenital disorders such as Pierre-Robinsyndrome. Disclosed herein are various embodiments of devices orimplants and methods for treating causes of airway obstruction.Embodiments described herein relate to, for example, adjustability,tethers, and anchors of those implants to treat said conditions. Alsodisclosed herein are methods and devices for deployment and retrieval ofthe implants disclosed. Some of such devices and methods are furtherdescribed in co-pending application Ser. No. 11/349,040, filed Feb. 7,2006, as well as in U.S. Patent Publication Nos. 2005/0092332 and2005/0092334 to Conrad et al. (herein, “Conrad”), which are herebyincorporated by reference in their entirety. References to figuresdisclosed in Conrad herein refer to Publication No. 2005/0092334. Invarious embodiments, Conrad discloses implants and methods of using theimplants to alter the geometry and position of the tongue and softpalate. Embodiments disclosed herein may also be adapted for use withthe PILLAR® system of Restore Medical (St. Paul, Minn.).

U.S. patent application Ser. No. 11/349,040, filed Feb. 7, 2006 andpublished Sep. 14, 2006 as U.S. Patent Pub. No. 2006-0201519 A1(“Frazier '519 publication”); U.S. Provisional Patent Application No.60/813,230, filed Jun. 13, 2006 (“'230 provisional application”); U.S.Provisional Patent Application No. 60/813,285, filed Jun. 13, 2006(“'285 provisional application); U.S. Patent Application No. 60/813,058,filed Jun. 13, 2006 (“'058 provisional application”); U.S. PatentPublication No. 2005/0092334 to Conrad et al (“Conrad”); U.S. Pat. No.6,250,307 to Conrad et al. (“Conrad '307”); U.S. patent application Ser.No. 11/762,642 filed Jun. 13, 2007 (“Dineen '642 application”); U.S.patent application Ser. No. 11/762,752 filed Jun. 13, 2007 (“‘Hirotsuka'752 application”); and U.S. patent application Ser. No. 11/762,652filed Jun. 13, 2007 (“Jackson '652 application”) are all incorporated byreference herein in their entirety.

Conrad discloses various methods and apparatuses for treating acondition of a patient's airway. FIG. 1 of Conrad illustrates an implant10 that may be completely implanted within the tongue T, oralternatively, the soft palate SP. The implant 10 comprises an elongatedmember 12 having a tissue in-growth end 14 and a static end 16. In someembodiments, as shown in FIG. 3 of Conrad, the elongated member 12a maybe resilient, e.g., in the form of a spring member which may bestretched to create a bias urging tissue in-growth 14a and static ends16a of the spring together. In some embodiments, the implant maycomprise a bioresorbable material 20 positioned between thetissue-engaging end 14a of the elongated member 12a and an anchor 18a.The tissue in-growth end 14a may be a tissue growth inducing material(e.g., felt or PET) to induce growth of tissue into the end to securethe end to surrounding tissue following implantation. An anchor 18a,positioned proximally (e.g., a threaded eye-bolt) is secured to themandible JB for tongue implants, and the hard palate HP for soft palateSP implants 10′. The static end 16 of the elongated member 12 is securedto the anchor 18. The tissue in-growth end 14 is placed in the tongue Tnear the tongue base TB. A surgeon adjusts the tension of the suture 12,causing the tongue base TB to be advanced toward the mandible JB therebyplacing the tissue of the tongue T in compression. The surgeon may tieoff the static end 16 at the anchor 18 retaining the tissue of thetongue T under tension. Other anatomical structures shown include thetrachea TR, epiglottis EP, esophagus ES, pharyngeal wall PW, trailingend of the soft palate TE, mouth M, and nasal cavity N.

In some embodiments, as shown in FIG. 11 of Conrad, tissue in-growthmaterial 118 deployed proximally acts as an embedded anchor andeliminates the need for placement of an anchor in the mandible JB.

Adjustment Mechanisms

As noted above, FIG. 1 of Conrad illustrates an implant 10 that includesan elongated member 12 (also referred herein as a tether or a tensionmember) having a tissue in-growth end 14 and a static end 16. In someembodiments, as shown in FIG. 3 of Conrad, the elongated member may beresilient, e.g., in the form of a spring member 12a which may bestretched to create a bias urging tissue in-growth 14a and static ends16a of the spring 12a together. In some embodiments, the implant 10a maycomprise a bioresorbable material 20 positioned between thetissue-engaging end 14a of the elongated member 12a and an anchor 18a.The tissue in-growth end 14a may be a tissue growth inducing material(e.g., felt or PET) to induce growth of tissue into the end to securethe end to surrounding tissue following implantation.

In some embodiments, the devices discussed above can also include one ormore adjustment elements, for example, one or more adjustment elementsselected from those described in the Frazier '519 publication (e.g.,those illustrated in FIGS. 61A-K of the Frazier '519 publication), the'230 provisional application (e.g., those illustrated in FIGS. 73-108 ofthe '230 provisional application), or the Dineen '642 application (e.g.,those illustrated in FIGS. 73-98 of the Dineen '642 application).Adjustment elements can advantageously allow for adjusting the tensionof the elongated member disclosed in Conrad after implantation of thetongue or palatal suspension system. A tongue or palatal remodelingsystem, device, and/or method for treating a patient with breathingproblems that can be adjusted either before, during and/or after theinitial implantation procedure may be better tolerated and less prone totreatment failure. For example, by being able to adjust the tension orbias of the elongated member disclosed in Conrad by methods other thanby cutting and re-tying the elongated member at times other than duringimplantation, migration, extrusion, and/or dysphagia may be avoided orcorrected.

For example, in one embodiment of the invention, shown schematically inFIG. 1 herein, the improved tongue suspension system 5020 includes oneor more spools or rotation assemblies 5020, such as a spool assemblyillustrated in FIGS. 61A to 61I of the Frazier '519 publication, foradjusting the tension of an elongated member 5012 between the mandibularanchor 5018 (attached to static end 5016 of the system) and the tissuein-growth end 5014 of the elongated member 5012, such as one disclosedin Conrad. A improved palatal suspension system 5030 is also shown inFIG. 1 that can be similar to the tongue suspension system, includingone or more spools or rotation assemblies 5020′ for adjusting thetension of an elongated member 5012′ between a bone or hard palateanchor 5018′ (attached to static end 5016′ of the system) and the tissuein-growth end 5014 of the elongated member 5102′ attached to the softpalate. In some embodiments, the elongated member may be configured toadjust the tension between a soft tissue anchor and the tissue ingrowthend.

Securement Assemblies

In some embodiments, the aforementioned implants may include one or moresecurement mechanisms selected from those disclosed in disclosed in theFrazier '519 publication, (e.g., securement mechanisms illustrated inFIGS. 40-51 of the Frazier '519 publication) which may be configured foruse a system such as the one disclosed in Conrad. For example, the boneanchor disclosed in Conrad may be replaced by a securement mechanism asdisclosed in the Frazier '519 publication. The securement mechanism maybe configured to hold the elongated member disclosed in Conrad or one ormore tethers disclosed in, for example, the Frazier '519 publication orthe Hirotsuka '752 application.

In one embodiment, illustrated schematically in FIG. 2, the tongue orsoft palate implant such as one disclosed in Conrad includes a boneanchor 186 with a clamping interface 188 for retaining tethers 28, asillustrated in connection with FIGS. 40A-C of the Frazier '519publication. The clamping interface 188 comprises two opposing surfaces190, 192 or structures that are adapted to provide a frictional ormechanical interface with tethers 28 or other elongate members insertedwithin the clamping interface 188. The clamping interface 188 has anopen configuration depicted in FIGS. 40A-C of the Frazier '519publication to allow positioning of one or more tethers 28 within theinterface 188 and a closed configuration shown for retaining the tethers28. The closed configuration may be achieved by crimping the twoopposing surfaces 190, 192 or by further structures of the clampinginterface, such as complementary clasps or clip structures to fix theopposing surfaces 190, 192 together. As shown in FIG. 40C of the Frazier'519 publication, the clamping interface 188 may further comprisecomplementary indentations 194 and protrusions 196 to further enhancethe frictional resistance of the interface in the closed configuration.The opposing surfaces or structures of the clamping interface may alsobe configured with frictional surfaces that are well known in the artthrough the use of various materials, surface treatments orconfigurations. Frictional surface configurations may also include crosshatched surfaces or irregular porous surfaces.

Tethers

As described above, Conrad teaches an elongated member having a tissuein-growth end and a static end. In some embodiments, as shown in FIG. 3of Conrad, the elongated member 12a may be resilient, e.g., in the formof a spring member 12a which may be stretched to create a bias urgingtissue in-growth 14a and static 16a ends of the spring together. Anelongated member, such as one disclosed in Conrad may include any one ofvarious tethers disclosed in the Frazier '519 publication (e.g., thoseillustrated in FIGS. 27-38 of the Frazier '519 publication), the '285provisional application (e.g., those illustrated in FIGS. 73-84 of the'285 provisional application), or the Hirotsuka '752 application (e.g.,those illustrated in FIGS. 73-80C of the Hirotsuka '752 application),and configured for use with the aforementioned Conrad tongue or palatalimplants. A tether with elastic properties or comprising structures thatprovide a length/tension relationship may be preferred in someinstances. A tether capable of lengthening in response to increased loador tension may be optimized to provide sufficient bias to reduce theeffects of oropharyngeal occlusion while providing a more physiologicrange of tongue or soft palate motion than that produced by fixed lengthtethers. Fixed length glossoplasty or suspension of the tongue may bethe cause of odynophagia, dysphagia and deglutition problems seen withexisting tongue remodeling devices, but the current invention is notlimited to this purpose. A tether with elastomeric properties may beprovided by using materials such as but not limited to urethane orsilicone. One skilled in the art can select the particular material,tether length, diameter, cross-sectional shape and other features basedupon the desired effect, tolerances, and the particular patient'sanatomical characteristics. Other materials that may comprise the tetherinclude but are not limited to Nitinol, spring steel, tantalum,polyethylene, polyester, silk, polypropylene, polyolefin or acombination thereof.

Other tether configurations that may be used include passive and activevariable length or bias structures such as braided or woven structures,electropolymers, springs, coils, magnets or solenoids. Thus, in some ofthe embodiments, the tether configuration may actively change in lengthor configuration resulting from the application of external energy orforce such as electrical current or magnets. These active tetherconfigurations may be further configured with local or distal sensorcomponents that may modulate the activity of the external energy orforce acting on the active tether. The modulation may be influenced ortriggered by detection of diaphragm movement or depolarization activity,nerve depolarization, pressure changes and/mechanical contact in theairway.

The tether may also be covered by a lubricious biocompatible coating. Inanother embodiment, the tether comprises a bioabsorbable coating thatmay cause scar or connective tissue formation about the tether. Scartissue formation may further enhance the effect of the glossoplastyimplant by tightening the tongue tissue (or similarly with regard to apalatal implant) and/or to resist migration of the implant.

In some embodiments, a tether of a tissue engaging member may beconfigured with one or more structures or surfaces capable of engagingat least a portion of the tissue surrounding the tether so that ananchor is not required, or to distribute the tissue engagement. In stillother embodiments, the tissue engaging member may comprise multipleanchors and multiple tethers arranged in a serial or branching fashion.

FIG. 3 illustrates an embodiment of tongue 5050 and soft tissue 5050′implants, both comprising a beaded tether 5040, 5040′, as disclosed in,for example, the Frazier '519 publication, the '285 provisionalapplication, and the Hirotsuka '752 application. The beaded tether 5040,5040′ may advantageously promote tissue in-growth and better tension thetongue 5050 or soft palate 5050′ suspension system. In otherembodiments, one or more tethers selected from the tethers disclosed inthe Frazier '519 publication, the '285 provisional application, or theHirotsuka '752 application replace the elongated member disclosed inConrad.

As illustrated in FIGS. 4A-4C, in one embodiment, an improved tonguesuspension system 5060 comprises a tether further comprising one or more“sling” elements 5062 on a tongue or palate-based implant system such asdisclosed in Conrad. The sling element 5062 may comprise, for example, abatten of porous fabric, woven material, a large diameter suture, braid,band, and the like. The sling element 5062 may be operably connected to,or replace the elongated member disclosed in Conrad. In someembodiments, the sling element 5062 comprises a central lumen configuredto receive one or more sutures within the lumen. The sling element 5062may alleviate trauma during installation of the tongue suspension system5060 because the enlarged suture portion 5062 need not be passed throughthe entire tongue T. The sling 5062 can also advantageously increaseanchoring surface area in the tongue T and prevent undesired migrationof the elongated member.

A method of deploying an improved tongue suspension system 5060comprising a sling element 5062 is disclosed herein, and illustrated inFIGS. 4A-4C. The method comprises the step of passing a first elongatedmember 5064 through the genioglossus muscle 5100 exiting the dorsumlateral to the midline. Next, a second elongated member 5066 is passedthrough the genioglossus muscle 5100 exiting the dorsum lateral to themidline on the contralateral side. Next, a sling element 5062 is passedunder the tongue T surface between exit holes created from the passingof the first 5064 and second 5066 elongated members through thegenioglossus muscle 5100. Then, elongated members 5064, 5066, such assutures are attached to each end of the sling element 5062. In someembodiments with a sling element 5062 that further include a lumen, theportion of the elongated member within the sling element may be securedwithin the lumen of the sling element 5062. The elongated members 5064,5066 outside of the sling element may then be attached to the boneanchor 5068. In another embodiment, the sling element 5062 is formedduring the procedure by passing a plurality of sutures transverselythrough the tongue along different pathways. The ends of the sutureslocated to each side of the midline tongue are then joined together toform the ends of the sling element. The in situ formed sling element canthen be attached to the first and second sutures as described above.

Tissue Engagement

As described above, Conrad teaches an elongated member having a tissuein-growth end. In some embodiments, as described with reference to FIG.11 Of Conrad, the elongated member 12 has two tissue in-growth ends(e.g., felt or PET); a proximal in-growth end 118 acting as an embeddedanchor eliminating the need for placing an anchor in the mandible, and adistal in-growth end 14 for tensioning the tongue suspension system. Inone embodiment of the present invention, a tongue suspension systemcomprises an implant with one or more anchors selected from the anchorsdisclosed in the Frazier '519 publication (e.g., as illustrated in FIGS.7-26 of the Frazier '519 publication), the '058 provisional application(e.g., as illustrated in FIGS. 73-112 of the '058 provisionalapplication), or the Jackson '652 application replacing the one or moretissue in-growth ends of a tongue or palatal implant disclosed inConrad. The anchors can advantageously improve tongue or palatalsuspension by providing a greater surface area and resistance tomigration of the implant. For example, in one embodiment as illustratedschematically in FIG. 5 herein, the tissue in-growth ends may comprisedouble-ended anchors 5080 as illustrated, for example, in FIGS. 86-112of the '058 provisional application, or the anchors of the Jackson '652application. The anchor may be operably connected to the elongatedmember as disclosed in Conrad, or a tether as disclosed in the Frazier'519 application, '058 provisional application, or the Jackson '652application as noted above. Other tissue ingrowth materials that may beused include polypropylene, polytetrafluoroethylenes, polyurethanes,polyesters, ceramics, porous metals or combinations thereof. In someembodiments, bioglues may be used to facilitate tissue adhesion to theimplant. Bioglues may be injected at the implantation site or providedas a coating on the implant. A bioglue coating may provided at the pointof manufacture or the point of service. In some embodiments, a tonguesuspension system may include a first tissue ingrowth portion and asecond tissue ingrowth portion, connected by a flexible elongate tether.The length and/or tension of the tether can be adjusted using anadjustment mechanism described herein, for example, a spool.

In some embodiments as shown in FIG. 5, soft palate implants, such asthose disclosed in Conrad may include one or more anchors 5082′ selectedfrom those disclosed in the Frazier '519 publication (e.g., FIGS. 63-69of the Frazier '519 publication) replacing the one or more tissueingrowth ends of the expandable member, for example, as illustrated inConrad FIGS. 1-2.

Another embodiment of an improved tongue or palatal suspension systemcomprises one or more tissue-engaging anchors 5090 as illustratedschematically in FIGS. 6A-B herein. The anchor 5090 may be deployeddistally, proximally, or both distally and proximally (relative to theposition of the tongue or the palate), and connected by a tether that ispreferably elongate and flexible in some embodiments. The anchor 5090may optionally comprise a plurality of “fish bone” shaped barbs 5092 inseries extending radially out from and operably connected at one end tothe anchor 5090 as illustrated. The angles of the barbs 5092 when fullydeployed may range anywhere from about 0 degrees to about 180 degreeswith respect to vector of insertion, preferably about 45 degrees to 135degrees, and most preferably about 60 degrees to about 150 degrees. Theangles of the barbs 5092 may be uniform or non-uniform along the lengthof the implant 5090. Although the barbs 5092 in FIGS. 6A-B are arrangedin pairs within a common plane of orientation, in other embodiments thebarbs 5092 may be unpaired and/or circumferentially arranged. The barbs5092 may be made of Nitinol, other metals, one or more polymers, orother suitable material. In some embodiments, the barbs 5092 may bebioabsorbable to decrease tissue irritation as well as to facilitatetissue ingrowth. In some embodiments, at least 1, 2, 3, 4, 5, 6, 7, 8,9, 10, or more barbs may be present. The anchor 5090 may be predeployedin a first, collapsed configuration, as schematically illustrated inFIG. 6A within a delivery tube (not shown). Upon removal of the deliverytube, for example, within the genioglossus muscle, the barbs 5092 springoutward to engage the tissue, as shown in FIG. 6B. The anchor 5090 maybe attached to an adjustable securement assembly as described above anddisclosed in the Frazier '519 publication. The adjustability isespecially advantageous when the anchor 5090 is placed untensioned, andtensioned at a later time after a healing and tissue ingrowth period.The anchor 5090 disclosed herein may also be configured for use for softpalate implants as disclosed in Conrad, as well as Conrad '307.

Conrad discloses several implants to stiffen the base of the tongue andresist floppy action or lack of tone in the tissue of the tongue nearthe base. For example, FIG. 8 of Conrad illustrates contracting implants40 that may be placed in the tongue T in-line with radiating lines A ofcertain muscles of the tongue (e.g., genioglossus muscles). As theimplants 40 contract over time, they urge the tongue T from collapsingtoward the pharyngeal wall PW. FIG. 12-13 of Conrad illustrates implants120 spaced apart for fibrosis to interconnect between the implants 120.FIGS. 14-17 of Conrad illustrate the use of embedded crimps or staples150 to stiffen and potentially illustrate the tongue base. In theembodiments shown in FIGS. 14-15, the crimps 150 are slightly curvedmembers which are placed in the tongue with concave surfaces opposingthe tongue base. The crimping acts to squeeze tissue of the tongue tostiffen the tongue.

In another embodiment, of the invention, disclosed is a multi-prongedstiffening element 5100, schematically illustrated implanted in a softpalate herein in FIGS. 7A-B. The stiffening element 5100 may have atleast about two, three, four, five or more prongs and be implanted, forexample, in the tongue, palate, and the like. The stiffening element5100 increases stiffness within the implanted tissue by stretching thetissue in one or more directions. In some embodiments, the tissue isstretched laterally. In some embodiments, the stiffening element 5100 istrident-shaped as shown. However, one of ordinary skill in the art willappreciate that many other possible shapes are possible. The stiffeningelement may be expandable after delivery.

Recapturability

FIGS. 8A-B illustrate an embodiment of an improved woven tissue implant5104 that can advantageously be easily removed, from, e.g., the tongueor the soft palate. The implant 5104 may be a batten type stiffener ortissue anchor formed from a single strand. The single strand can bewoven or knitted into a desired shape, for example, a rod-likestructure. The woven tissue implant 5104 may be deployed into tissue tostiffen a particular area and serve a similar function to the implantsillustrated in FIGS. 8 and 12-17 of Conrad or implants of the PILLAR®system (Restore Medical), or attached to one or more tethers for use asa tissue anchor or sling. The woven design facilitates tissue ingrowthwithin the spaces around the woven implant 5014, effectively increasingthe surface area of the implant 5104 and increasing the implant'sanchoring force. The implant 5104 is most preferably configured to havesufficient structural integrity necessary to anchor tissue. However, thewoven implant 5104 is also preferably configured such that pulling on anend of the single strand of the implant with an appropriate force willunwind or unravel the implant 5104 into a long filament (as shown inFIG. 8B) for simple and convenient removal of the implant. Theappropriate force required to unwind the implant 5104 is most preferablysufficiently greater than the tensioning force of the tissue on theimplant 5104 while deployed in the tongue, palate, or surrounding tissueso that the implant 5104 does not undesirably unwind while deployed.Part or all of the implant 5104 may include a radiopaque markermaterial.

As illustrated in FIG. 3 of Conrad, the implant may comprise abioresorbable material 20 positioned between the tissue-engaging end 14aof the elongated member 12a and an anchor 16a. The bioresorbablematerial 20 may oppose a spring member 12a which may be stretched tocreate a bias urging ends 14a, 16a of the elongated member 12a towardone another. The bioresorbable material 20 positioned between thetissue-engaging end 14a and a bolt 18a will later resorb into the tissueof the tongue T permitting the end to be urged toward the bolt 18a bythe resilience of the spring 12a, tensioning the device.

FIG. 9 herein illustrates an improved embodiment of a tether 5108 thatmay be used with tissue ingrowth implants, such as, for example, thosedisclosed in Conrad. An improved tether 5108 comprises a locking bar5112 releasably attached to both the tissue ingrowth end 5014 and thebone anchor 5018 (or both tissue ingrowth ends in some embodiments) anddisposed within an elastic member 5110. The elastic member 5110 ispreferably connected to an implant or anchor 5014 (such as the tissueingrowth engaging member of Conrad) at a first end and a securingelement 5018 (such as a bone anchor) or another tissue anchor at asecond end. The locking bar 5112 may comprise one or more forked orcapped ends 5113. The locking bar 5112 may comprise metal, polymer, orother biocompatible material, but preferably has a relatively lowelasticity to prevent migration of the implant or anchor 5014 in theacute post-implantation period. During this period, there may beinadequate tissue ingrowth for the implant or anchor 5014 to provide asufficient anchoring force to tension the tether 5110. Other tethersthat can also be used to provide a temporary or permanent anchoringforce are disclosed in, for example, the Frazier '519 publication, the'285 provisional application, and the Hirotsuka '752 application.

The locking bar 5112 provides the appropriate anchoring force untiladequate tissue ingrowth occurs and the elastic member 5110 can beappropriately tensioned (as an alternative, for example, to thebioresorbable material solution illustrated in FIG. 3 of Conrad). Whenadequate tissue ingrowth occurs, the locking bar 5112 may be removed viaa recapture tool as disclosed elsewhere in the application and theFrazier '519 publication (e.g., at FIGS. 70-72 of the Frazier '519publication). The locking bar 5112 can be accessed via a surgicalprocedure and pulled out manually. In other embodiments, the locking bar5112 may comprise a tether line running to the bone anchor 5018 whichcan be used with a percutaneous recapture system, such as the systemdisclosed in the Frazier '519 publication, for removal. A dilator toolcan follow the tether to an end of the locking bar 5112, and the lockingbar 5112 could then be pulled out. If the locking bar 5112 is made froma smooth material (e.g., a metal or plastic rod) the tether line can bepulled directly to remove the bar without the need for a dilator tool.In some embodiments, the locking bar 5112 may be made of a biodegradablematerial, such as polylactic acid, polyglycolic acid and the like, thatdegrades at a rate slow enough to continue to provide anchoring force tothe implant 5014 until adequate tissue ingrowth allows the elasticmember 5110 to be appropriately tensioned.

Various devices and methods to promote recapturability and removal of abatten implant, such as, for example, implants illustrated in FIGS. 8and 12-17 of Conrad, implants disclosed in U.S. Pat. No. 6,250,307 toConrad et al., and the PILLAR® System (Restore Medical) are disclosed.An improved batten-style implant 5120, illustrated in FIGS. 10A-Cherein, comprises one or more cap elements 5122. The cap elements 5122are preferably attached to the proximal end, distal end, or both ends ofthe batten implant. In some embodiments, the cap element 5122 covers asubstantial portion, or even the entire batten implant 5120. The capelement 5122 may be made of, for example, plastic, metal, Dacron, ePTFE,and the like. In some embodiments, the cap element 5122 comprisesradiopaque material such that the cap 5122 can be visualized on plainfilm radiographs. In other embodiments, the cap element 5122 comprisesmaterial that can be visualized on ultrasound, magnetic resonanceimaging, or other imaging modalities.

The cap elements 5122 can advantageously assist in guiding an implantremoval device, such as a cannula 5124, onto the main body of theimplant 5120 such that the cutting edges of the removal device 5124 canseparate the fibrous encapsulation near the implant surface withoutcutting into, or otherwise damaging the implant body 5120. The capelements 5122 may be especially advantageous when the implant 5120 istethered, for example, when the implant 5120 is used as a tissue anchorto apply traction to the tongue or the palate. Thus, the cap elements5122 may allow the batten implant 5120 to readily and safely removedfrom tissue while minimizing tissue trauma and reducing the risk ofdamage to the implant 5120 complicating removal through increased forceor cutting or tearing of the implant 5120.

A method for recapturing a batten implant 5120 will be described. First,trailing sutures 5012 are threaded through a dilator with a cannulaassembly 5124, such as a recapture tool depicted in FIGS. 7G to 7J andFIGS. 70-72 of the Frazier '519 publication. Next, the cannula anddilator 5124 (shown schematically as a single cannula for simplicity inFIGS. 10B-C) are advanced over the sutures 5012 and through tissue tothe batten implant 5120. In batten implant 5120 embodiments thatcomprise an imaging marker, the cannula and dilator 5124 may be guidedby, for example, an appropriate technique to detect the imaging marker,such as fluoroscopy, ultrasound, CT, MRI, and the like. Fibrous tissuemay be dissected from the sutures 5012 using the dilator 5124. Then, inembodiments of implants 5120 that comprise one or more cap elements5122, the cannula 5124 is advanced over the implant 5120 when thedilator 5124 reaches the cap element 51. The cap element 5122 ispreferably configured to be harder in texture than the surroundingperi-implant fibrous tissue, allowing the cannula 5124 to be guided overthe implant body 5120 without cutting the softer material of the implantbody. Next, the implant 5120 and recapture assembly 5124 is removed.

Delivery Systems

The various embodiments disclosed in Conrad as well as the embodimentsof the present invention disclosed herein may be deployed within adelivery system, such as the delivery system disclosed in the Frazier'519 publication (e.g., the delivery system illustrated in FIGS. 62A-Dof the Frazier '519 publication). In one embodiment, as illustrated inFIGS. 62B-C of the Frazier '519 publication, a delivery tool comprises apushrod attached to an actuator handle, the pushrod having a distalposition and a proximal position which can be manipulated by a userthrough the actuator handle. An implant comprising a tissue ingrowthend, static end, and an elongated member, therebetween, such as, forexample, an implant illustrated in FIGS. 1-4 of Conrad, may be loadedinto the delivery tool by attaching the end(s) of the elongated memberto an attachment site on a spool within the delivery tool. When theelongated member is attached to the spool and the dial attached to thespool is rotated, the elongated member, including the tissue ingrowthend, are pulled into the tubular body as the elongated member is woundaround the spool. The proximal pulling of the tissue ingrowth end intothe delivery tube causes the tissue ingrowth end to retract into arelatively compact delivery profile configuration and into the tubularbody. When the actuator handle is moved from the loading position to thedeployed position, the actuator handle overcomes the bias of theresistance structure to release the rotation resistance. This allows thespool to freely rotate and to quickly deploy the tissue ingrowth end,followed by the rest of the elongated member, into the tissue. The speedwith which the tissue ingrowth end is deployed may affect the degree oftissue engagement by the tissue ingrowth end. In some instances, it isdesirable to reduce rotation resistance in the delivery phase comparedto the loading phase of the delivery tool usage.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For example,in some embodiments, a tongue or soft palate implant may have one ormore elements of different embodiments described herein, for example,one or more anchors disclosed in the Frazier '519 publication, '058provisional application, or Jackson '652 application and one or moreadjustment elements described in the Frazier '519 publication, '230provisional application, or the Dineen '642 application. Furthermore,the invention encompasses other combinations of any or all of thedisclosures of the aforementioned references. For all of the embodimentsdescribed above, the steps of the methods need not be performedsequentially.

1. A tissue tensioner for treating a condition of a patient's airway comprising: a flexible, elongate elastic member having a first portion and a second portion, wherein the first portion is configured to be secured relative to a body tissue and the second portion is connected to a tissue ingrowth material; and a locking bar releasably attached to the first portion and the second portion, the locking bar configured to prevent migration of the first portion relative to the second portion.
 2. A method for treating a condition of a patient's airway, the method comprising: positioning a tissue tensioner within a patient, the tissue tensioner comprising a flexible, elongate elastic member having a first portion secured relative to a body tissue and a second portion comprising a tissue ingrowth material implanted in a portion of the tongue, wherein a locking bar is releasably attached to the first portion and the second portion to prevent migration of the first portion with respect to the second portion; and manually pulling out the locking bar to allow migration of the first portion with respect to the second portion. 